Safety and Pharmacokinetics Study of FBF001

Summary

The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.

Timeline

Start

2012-10

Primary completion

2012-12

Completion

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Publications

• Bal C, Herbreteau CH, Buchy P, Rith S, Zaid M, Kristanto W, Han V, Reynaud C, Granjard P, Lepine B, Durand C, Tambyah PA. Safety, potential efficacy, and pharmacokinetics of specific polyclonal immunoglobulin F(ab')(2) fragments against avian influenza A (H5N1) in healthy volunteers: a single-centre, randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2015 Mar;15(3):285-92. doi: 10.1016/S1473-3099(14)71072-2. Epub 2015 Feb 5.

Drugs

Indications